FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPT OPEN ACCESS PORT, MODEL 41233
K Number: K021731
·
Decision Aug 8, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
16
Review Days
76
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADAPT OPEN ACCESS PORT, MODEL 41233
- K Number
- K021731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Taut, Inc.
- Date Received
- May 24, 2002
- Decision Date
- August 8, 2002
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Taut, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023261 | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 | Dec 13, 2002 | Substantially Equivalent |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | Jun 22, 2001 | Substantially Equivalent |
| K003703 | TAUT-INSUFFLATION NEEDLE | Feb 22, 2001 | Substantially Equivalent |
| K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | Feb 22, 2001 | Substantially Equivalent |
| K992904 | MINI-PORT | Oct 5, 1999 | Substantially Equivalent |
| K992907 | INTRADUCER | Oct 5, 1999 | Substantially Equivalent |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Dec 1, 1997 | Substantially Equivalent |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | Jul 18, 1996 | Substantially Equivalent |
| K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 | Mar 20, 1996 | Substantially Equivalent |
| K945486 | SPLATTER CONTROL SHIELD | Feb 28, 1995 | Substantially Equivalent |